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Impact of Bread Diet on Intestinal Dysbiosis and Irritable Bowel Syndrome Symptoms in Quiescent Ulcerative Colitis

I

Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Status

Completed

Conditions

Ulcerative Colitis in Remission

Treatments

Dietary Supplement: Treatment vs control bread

Study type

Interventional

Funder types

Other

Identifiers

NCT05656391
RTC-2017-CU

Details and patient eligibility

About

The present study aimed to compare the in vivo prebiotic properties of bread produced by traditional breadmaking techniques with that made using a modern breadmaking method on Irritable Bowel Syndrome-like symptoms in patients with quiescent Ulcerative Colitis. The expected outcome of the differential effects was a change in the faecal microbiome composition, which may indicate changes in the mucosa-associated microbiota.

Enrollment

31 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients diagnosed with ulcerative colitis according to established clinical and histological criteria as common clinical practice
  • Remission of ulcerative colitis defined as a total Mayo score ≤2 and faecal calprotectin values under 250 ng/g
  • Subjects aged over 18 years
  • Moderate-to-severe IBS-like symptomatology defined by Rome IV criteria and IBS Symptom Severity Score (IBS-SSS) > 175.

Exclusion criteria

  • Presence of flare-up of UC
  • Coeliac disease, colectomy, or intestinal resection
  • Antibiotic intake, prebiotic or probiotic treatment within 3 months before the study
  • Any malignancy, pregnancy, or breastfeeding
  • Intake of medication potentially influencing gastrointestinal function
  • Disability to give informed consent

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

31 participants in 2 patient groups, including a placebo group

Treatment bread
Active Comparator group
Description:
Dietary treatment consisted of daily consumption of 200 grams of bread produced following traditional breadmaking techniques
Treatment:
Dietary Supplement: Treatment vs control bread
Control bread
Placebo Comparator group
Description:
Dietary treatment consisted of daily consumption of 200 grams of bread produced following modern breadmaking techniques
Treatment:
Dietary Supplement: Treatment vs control bread

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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